After working to build its GLP-1 manufacturing capacity for years, Novo Nordisk has submitted for FDA approval of an oral version of obesity treatment Wegovy. (Novo Nordisk)
Nearly two years after reporting successful results from a phase 3 trial of its oral version of injected obesity treatment Wegovy, Novo Nordisk has asked the FDA to approve it. Learn more about our GLP-1R/GCGR/GIPR catalog.
A company spokesperson confirmed the FDA submission, which was reported Monday by BioPharma Dive. Novo plans to provide more information during its quarterly results presentation May 7, the spokesperson said.
It is unusual for a company to not voluntarily announce an FDA new drug submission. It also is rare that a submission comes two years after the presentation of successful results of a pivotal trial.
In May 2023, when Novo reported that patients on the highest dose (50 mg) of oral semaglutide lost 15% of their weight after 64 weeks, the company said it planned to apply for approval by the end of that year.On Tuesday, a company spokesperson said that Novo was "awaiting the results from the entire OASIS program to include a full package for submission."
For the last few years, Novo has been focused on trying to meet the skyrocketing demand for Wegovy and diabetes drug Ozempic. With the company struggling to increase its production of the glucagon-like peptide-1 (GLP-1) treatments, finding additional capacity to manufacture oral semaglutide—provided it won approval—was a secondary priority for the company.
